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Author : Steven E. Linberg
Publisher :
ISBN 13 : 9781882615513
Total Pages : 527 pages
Book Rating : 4.6/5 (155 download)
Download or read book Expediting Drug and Biologics Development written by Steven E. Linberg and published by . This book was released on 1999-12-01 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Steven E. Linberg
Publisher :
ISBN 13 : 9781882615254
Total Pages : 380 pages
Book Rating : 4.6/5 (152 download)
Download or read book Expediting Drug and Biologics Development written by Steven E. Linberg and published by . This book was released on 1995-01-01 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ronald Evens
Publisher : Springer Science & Business Media
ISBN 13 : 0387690948
Total Pages : 394 pages
Book Rating : 4.3/5 (876 download)
Download or read book Drug and Biological Development written by Ronald Evens and published by Springer Science & Business Media. This book was released on 2007-08-18 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Author : Mark Mathieu
Publisher : Barnett Educational Services / Chi
ISBN 13 : 9781882615674
Total Pages : 283 pages
Book Rating : 4.6/5 (156 download)
Download or read book Biologics Development written by Mark Mathieu and published by Barnett Educational Services / Chi. This book was released on 2004-01-01 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
Author : Wei Wang
Publisher : John Wiley & Sons
ISBN 13 : 1118695224
Total Pages : 531 pages
Book Rating : 4.1/5 (186 download)
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Author : Xiaodong Feng
Publisher : CRC Press
ISBN 13 : 0429939299
Total Pages : 529 pages
Book Rating : 4.4/5 (299 download)
Download or read book Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022-06-13 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Author : C. Robin Ganellin
Publisher : Academic Press
ISBN 13 : 0123977703
Total Pages : 469 pages
Book Rating : 4.1/5 (239 download)
Download or read book Introduction to Biological and Small Molecule Drug Research and Development written by C. Robin Ganellin and published by Academic Press. This book was released on 2013-05-07 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development
Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118659988
Total Pages : 744 pages
Book Rating : 4.1/5 (186 download)
Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-09-19 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
Author : Charles E. Hamner
Publisher : CRC Press
ISBN 13 : 0429557469
Total Pages : 470 pages
Book Rating : 4.4/5 (295 download)
Download or read book Drug Development written by Charles E. Hamner and published by CRC Press. This book was released on 2019-06-12 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309457971
Total Pages : 145 pages
Book Rating : 4.3/5 (94 download)
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Author : Peter L. Bonate
Publisher : Springer
ISBN 13 : 3319390538
Total Pages : 336 pages
Book Rating : 4.3/5 (193 download)
Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer. This book was released on 2016-10-06 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.
Author : Elaine Whitmore
Publisher : Quality Press
ISBN 13 : 0873892216
Total Pages : 257 pages
Book Rating : 4.8/5 (738 download)
Download or read book Development of FDA-Regulated Medical Products written by Elaine Whitmore and published by Quality Press. This book was released on 2012-02-15 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.
Author : Xiaodong Feng
Publisher : CRC Press
ISBN 13 : 9781138594227
Total Pages : 510 pages
Book Rating : 4.5/5 (942 download)
Download or read book Biologics and Biosimilars written by Xiaodong Feng and published by CRC Press. This book was released on 2022 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biologics and Biosimilars: Drug Development and Clinical Affairs is a systematic integration and evaluation of all aspects of biologics and biosimilars, R&D and clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologics with high similarities in structure, efficacy and safety. Most of the top selling prescription drugs in the current market are biologics, which revolutionized the treatment strategies and modalities for life-threatening and rare diseases. This book outlines the key processes and challenges in drug development, regulations and clinical applications of biologics, biosimilars and bioequivalences. Professionals in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice including, allergenics, blood and blood components, cells, gene therapy, recombinant therapeutics proteins, tissues, and vaccines. Additional Features include: Integrates the latest bench and bed side evidences of drug development and regulations of biologics and biosimilars Features key study questions for each chapter to guide the reading as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations and clinical applications of biologics and biosimilars This book is an invaluable tool for the pharmaceutical and health care industries, as well as the public. It both educates and updates the reader about the drug development and clinical affairs of biological medications and their similar drugs.
Author : Chi-Jen Lee
Publisher : CRC Press
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.:/5 (31 download)
Download or read book Development and Evaluation of Drugs written by Chi-Jen Lee and published by CRC Press. This book was released on 1993-07-06 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Development and Evaluation of Drugs presents a comprehensive description of the development and evaluation of drugs and provides valuable information that will help you understand the regulatory processes of government agencies, especially the U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health and Welfare. The book also analyzes various problems of manufacturing practices in the pharmaceutical industry, discusses aspects of drug interactions and responses, and examines methods for promoting health and preventing diseases. Development and Evaluation of Drugs will be excellent for investigators in medical research and pharmaceutics. It will also be useful to health scientists, managers, and personnel in regulatory agencies. Features
Author : Mark P. Mathieu
Publisher : Omec
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)
Download or read book New Drug Development written by Mark P. Mathieu and published by Omec. This book was released on 1987 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Eli Lilly and Company Biologic Dept
Publisher : Legare Street Press
ISBN 13 : 9781020406522
Total Pages : 0 pages
Book Rating : 4.4/5 (65 download)
Download or read book The Elements Of Biologics: Recurrent Questions And Answers written by Eli Lilly and Company Biologic Dept and published by Legare Street Press. This book was released on 2023-07-18 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a detailed guide to the development and use of biologic drugs. The author covers a wide range of topics including research and development, clinical trials, manufacturing, and more. It is a valuable resource for anyone working in the biotech industry. This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Author : Daria Mochly-Rosen
Publisher : Springer Science & Business Media
ISBN 13 : 3319022016
Total Pages : 186 pages
Book Rating : 4.3/5 (19 download)
Download or read book A Practical Guide to Drug Development in Academia written by Daria Mochly-Rosen and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
